What is a Participant Information and Consent Form?
The Participant Information and Consent Form (PICF, or Consent Form) will ask you if you permit BioGrid Australia, on behalf of the HHT Alliance, to contact you in the future. There are 4 options (described below) for you to consider and you may choose “Yes” or “No“ for each level of consent depending on what you think is best for you.

The 4 levels of consent
Consent Level 1:
You will be asked if you give permission for BioGrid Australia to store your medical information as data in the HHT Database and for it to be used in a re-identifiable (coded) way, for example looking at how many patients with a particular genetic condition we have information for and what are the basic characteristics of those patients.

Consent Level 2:
You will be asked if you give permission for BioGrid Australia to contact you for an update of your personal information. This is to find out what has happened to you since you last gave us your information. Again, this information would be stored and used in a reidentifiable (coded) way as in Level 1.

Consent Level 3:
You will be asked if you give permission for BioGrid Australia to contact your doctor to obtain your medical details to confirm details of your rare genetic condition. This is so that the information we store is as accurate as possible. Again, this information would be stored and used in a re-identifiable (coded)

Consent Level 4:
You will be asked if you give permission for BioGrid Australia to contact you about the possibility of participation in other ethically approved research projects studying your type of genetic condition.

What information will be on The HHT Database?
Identifying information
If you agree to participate in this study, we will record your name, date of birth, address and whether you reside in Australia. This will then be stored on the HHT database in a coded format by creating a unique code for you. Only this unique code will be attached to your clinical information.

Clinical information
We will ask you for clinical data such as your age, data of first diagnosis, how the diagnosis was made, who your doctors were at the time, what treatments you had and whether anyone else in your family has HHT. This information will be stored separately from your identifying information (i.e. in a different computer database) and will be identified only by your unique code.

Who will use my information?
Information in the HHT database can only be used for the activities agreed to in the Consent Form. In addition, this information can only be used by doctors and scientists for research that has been approved by a Human Research Ethics Committee.

For a researcher applying to gain access to the database, the following requirements must be met before data access can be granted.

• The HHT Alliance project leader must review each request to access the HHT database for a proposed project. This ensures that the data is only used for appropriate research projects that are of potential interest to the HHT Alliance and its collaborators.
• Projects must then undergo peer-review to ensure it is of high scientific quality that has the potential to inform and/or improve current clinical practice. Project reviewers are qualified doctors and scientists.
• Projects are also reviewed by a Human Research Ethics Committee accredited by the Australian National Health and Medical Research Council (NHMRC). The role of these committees is to ensure all research is conducted in accordance with the National Statement on Ethical Conduct in Research Involving Humans (2007).

Once these requirements have been satisfied, researchers are provided with access to the HHT database for the purposes of their approved project. Importantly, researchers can only access information relating to participants who have submitted a signed Consent Form.

How can my information be accessed?
The application, review and approval process is managed by BioGrid Australia, a not-for-profit charity that is owned by hospitals, universities and medical research institutes around Australia. BioGrid specialise in providing secure research data services to the health and medical research sector. For more information, please refer to the BioGrid Australia website at: www.biogrid.org.au.

How will my privacy be protected?
All information entered into the HHT database is stored in a password-protected, secure computer facility at Melbourne Health. Importantly, approved researchers never receive your identifying information and are cannot determine who you are based on your clinical information alone.

When you enter your information into the HHT database, you are assigned a unique code. As your identifying (i.e. name, address, etc.) and clinical (i.e. diagnosis, treatment, etc.) information are stored separately, this code allows researchers to conduct their project without ever knowing who you are. This code also allows the HHT Alliance to contact you without any need to access your clinical information. Importantly, your identifying information is used to contact you only:

• Where you have provided your consent, and
• For the reasons described in the Participant Information and Consent Form.

All your data is stored securely at Melbourne Health. Access to your unique code linking your identifying and clinical information is limited to IT staff responsible for managing the HHT database; these staff cannot access your clinical information.

In accordance with relevant Australian and/or Victorian privacy and other relevant laws you have the right to access the information collected and stored by the researchers about you. You also have the right to request that any information with which you disagree be corrected. Please contact one of the researchers named below if you would like to access your information. Any information obtained in connection with this project and that can identify you will remain confidential. It will only be disclosed with your permission, except as required by law.

How do I know that my information will be used in a way I would want?
Your information will only be used for purposes that you have agreed to on your signed Consent Form. If at any stage you wish to change or withdraw your consent, please complete a Form for Withdrawal of Participation or a new Consent Form (available from the HHT website) and send this to us. Alternatively, please contact us at hht@mh.org.au.

How long will it take to complete the questionnaire?
The questionnaire is separated into 9 sections. Depending on how much information you provide, it will take about 20 to 30 minutes to complete. You do not have to answer all questions in one session. Once registered you can start the questionnaire and save your information at anytime. You do not have to answer all the questions in one session. You can come back to complete or modify the questionnaire at a later date.

Can I get someone else to fill out the questionnaire on my behalf?
Yes, but only with your permission (controlled by access to your login details). This may be a friend, relative or one of your treating doctors. Please note that the questionnaire has been structured so that the questions are directed to you (i.e. the patient). If someone is completing the questionnaire on your behalf, this person should interpret the questions as if he or she was the patient and answer accordingly.

What if I don’t have time to finish the questionnaire?
You do not have to answer all questions in one session. After registration, can come back to complete or modify the questionnaire at a later date.

Can I go back to the last questions?
Yes. You can navigate backward and forward through the questionnaire as much as you like. You have two options to do so:

• Use the “Save and Back” or “Save and Next” buttons at the bottom of each page of the questionnaire.
• Use the Progress Menu Bar (1-9, Summary) towards to the top of each page of the questionnaire. You may wish to review the "Summary" page to determine which questions you need to complete/edit without reviewing the entire questionnaire.

What if I’ve made a mistake?
If you make a mistake, you can go back to the question and edit your answers. The “Summary” screen allows you to review your responses.

Can I print out what I’ve done?
Yes. This is an option to “Print” your responses to the questionnaire on the top right corner of the “Summary” page. Alternatively, you may "Save" your responses to computer file by selecting “Print” and changing “Print Destination” to PDF file.

Do I have to do the pages in order?
No. You can navigate backward and forward through the questionnaire as much as you like. You have two options to do so:

• Use the “Save and Back” or “Save and Next” buttons at the bottom of each page of the questionnaire.
• Use the Progress Menu Bar (1-9, Summary) towards to the top of each page of the questionnaire. You may wish to review the "Summary" page to determine which questions you need to complete/edit without reviewing the entire questionnaire.

Can I show my printout to my doctors?
Yes. You can show it to anyone who you think might be helpful for you.

Is there someone at the HHT Alliance I can contact with questions about The HHT Database?
Yes. Please send an email including any questions/enquiries to hht@mh.org.au

What if I am not sure of an answer?
If you don’t know the answer, please simply leave the field empty or select "I don’t know" or "Other", if that option is provided.

Must I answer everything? Can I leave things out and come back later to enter the info in?
You do not have to answer every question. You can answer the questions you know and come back at a later time when you have more information. If you don’t know the answer, you can leave the field blank.

What if my contact details change?
If your contact details change please login to the HHT Alliance Website and go to "Patient Information" section of the questionnaire to edit your information. You can review this changes by going to the “Summary” screen to ensure the details have been changed correctly.

Can I update the questionnaire if I get more information?
Yes, you can come back to complete or modify the questionnaire at a later date. Simply login to the HHT Alliance website using your registered username/email and password.